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- 2026-04-03 16:43:03
- Policy
- Measures to ban imports of psychotic dietary supplements
- by Lee, Hye-Kyung Jul 28, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) announced on July 25 that the Ministry is designating '7-Hydroxymitragynine,' an ingredient that is narcotic (antipsychotic), as a prohibited material and ingredient for import into South Korea. This measure was implemented to ban overseas direct purchase of dietary supplements, gummies, or drink mixes containing '7-Hydroxymitragynine.' The newly designated 7-hydroxymitragynine is an ingredient classified as a psychotropic substance under 'The Narcotics Control Act.' It is an alkaloid component present in small amounts in the Southeast Asian plant Mitragyna speciosa (scientific name), commonly known as Kratom. It is known to pose a serious risk to human health if misused or abused. The Ministry of Food and Drug Safety is strengthening the safety management of overseas direct-purchase foods. To this end, it designates ingredients and raw materials (such as narcotics, medicinal and traditional Korean medicine ingredients) in overseas direct-purchase foods that pose a risk to public health and need to be blocked from domestic entry, as raw materials/ingredients subject to domestic import blockage. Furthermore, considering that consumers find it difficult to identify harmful ingredients/raw materials, MFDS also provides an easily understandable list of products containing harmful ingredients (3,800 items). Therefore, it is vital for consumers first to check the 'Overseas Direct Purchase Foods' section on the 'FoodSafetyKorea' website before purchasing overseas direct-purchase foods. MFDS stated, "We plan to continue providing consumers with information on precautions and harmful substances when purchasing overseas direct purchase foods."
- Company
- Mounjaro launch set for August in Korea
- by Whang, byung-woo Jul 25, 2025 06:11am
- The launch date for Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, has been set, signaling the start of full-fledged competition in the obesity treatment market in Korea. Lilly Korea announced on the 23rd that it will launch Mounjaro 2.5mg and 5mg/0.5mL in mid-August for patients with type 2 diabetes and obesity in Korea. Mounjaro is the first and currently only dual GIP (glucose-dependent insulinotropic polypeptide)/GLP-1 (glucagon-like peptide-1) receptor agonist. It is a single-molecule injection designed to selectively bind to and activate the GIP receptor and GLP-1 receptor with once-weekly administration. It helps lower blood glucose levels by promoting insulin secretion, improving insulin sensitivity, and reducing glucagon levels, as well as reducing food intake and body weight through delayed gastric emptying. Domestic and international clinical guidelines, as well as the World Health Organization (WHO), classify Mounjaro as a distinct class of therapy apart from existing GLP-1 receptor agonists based on its mechanism of action and the results of the Phase III SURPASS and SURMOUNT clinical trials. Mounjaro is currently indicated in Korea as an adjunct to diet and exercise (monotherapy or combination therapy) for improving blood sugar control in adult patients with type 2 diabetes, and for chronic weight management in adults with obesity (initial BMI ≥ 30 kg/m2) or overweight (initial BMI 27 kg/m2 ≤ BMI) with at least one weight-related comorbidity.
- Company
- Verzenio fails to pass third CDDC review for reimb in KOR
- by Eo, Yun-Ho Jul 25, 2025 06:10am
- Unfortunately, the third time was not the charm. The breast cancer treatment Verzenio is facing difficulties in expanding insurance reimbursement for early breast cancer in Korea. On the 23rd, Lilly Korea’s CDK4/6 inhibitor Verzenio (abemaciclib), which sought to secure reimbursement for its early breast cancer indications, failed to pass the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDRC). This is already the company’s third failed attempt.. The reason for the committee not establishing Verzenio's reimbursement criteria is believed to be the lack of overall survival (OS) data. However, OS data is difficult to obtain for drugs with early-stage cancer indications such as Verzenio. In fact, overall survival (OS) has been the main reason many drugs fail to pass the CDRC review. This has become one of the biggest points of contention among pharmaceutical companies with oncology portfolios regarding the committee’s evaluation criteria. Verzenio faced difficulties in being reviewed by the CDRC in its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDRC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March last year, it was submitted to CDRC for review, facing the same results. The reimbursement of Verzenio for early breast cancer has been a long-standing hope among patients. In fact, a national petition calling for the expansion of reimbursement for Verzenio has garnered more than 50,000 signatures. The 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress reaffirmed the drug’s clinical efficacy for early breast cancer. This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium and Lancet Oncology in December 2022. Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4. At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms. This data suggested that even for those who received treatment with Verzenio for the limited period of 2 years after surgery, the treatment benefit persisted on to year 5. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer. The drug’s indication was expanded on November 18th, 2022, as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, the drug is indicated for a very limited range of patients at high-risk of relapse: ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes and a tumor size of 5 cm or larger, or ▲histological grade 3 disease. Professor Keun Seok Lee from the Breast Cancer Center of the National Cancer Center said, “The Verzenio+endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”
- Opinion
- [Reporter's View] Denmark's corporate model, Wegovy success
- by Jul 25, 2025 06:10am
- I recently had the opportunity to visit the biotech industry in Denmark. I toured facilities like Novo Nordisk, which rose to stardom with its GLP-1-based obesity treatment Wegovy, as well as LEO Pharma, with its 117-year history, and Lundbeck, a powerhouse in the central nervous system field. What struck me was that all these companies, without exception, cited their 'foundation-owned governance structure' as the secret to Denmark's biotech industry competitiveness. Denmark has Europe's most structured foundation-owned model. Approximately 1,300 companies in Denmark operate under a foundation-owned structure. Pharmaceutical companies like Novo Nordisk, LEO Pharma, and Lundbeck, as well as the toy company Lego, brewery Carlsberg, and shipping giant Maersk, all adopt governance structures where a foundation is the largest shareholder. Examining the governance structure of these companies reveals that non-profit foundations run them. A foundation controls an intermediate holding company, which is also a professional investment firm. This holding company, in turn, oversees various operating companies. It can be summarized as 'Foundation → Holding Company → Operating Company,' where the foundation indirectly controls its subsidiaries through a holding company-style investment firm. Foundations support the life sciences field in all-in efforts. The Novo Nordisk Foundation boasts one of the largest asset sizes globally, with Assets Under Management (AUM) reaching approximately $140 billion (KRW 194 trillion). Thisfigure is more than twice the AUM of the Bill & Melinda Gates Foundation, North America's largest private foundation, which stands at $69 billion. Such investment strengthens Denmark's scientific foundation nationwide and effectively attracts top talent from around the world to Denmark. A unique aspect of the Danish foundation-owned model is that the founding family does not serve as the largest shareholder of the operating company, nor do they directly hold equity. While some foundations may have founding family members play a symbolic role on the board, they do not exercise substantial control over the organization. Denmark has thus created a corporate ecosystem that perpetuates the founder's philosophy through a foundation while separating equity ownership from operational management. Due to this clear separation of ownership and management, companies can consistently pursue long-term strategies without being influenced by short-term performance. Being free from the pressures of short-term profits from external investors or shareholders creates an environment where companies can concentrate on long-term research and development (R&D) while delivering public value. Unlike private equity funds, which seek short-term returns based on profit, foundations can respond flexibly regarding equity maintenance or exit timing. In my opnion, this Danish case could offer significant implications for the direction the Korean pharmaceutical industry should take as it faces a transition in its governance structure. With the succession to the 3rd or 4th generation of founders gaining momentum, many Korean pharmaceutical companies are seeking solutions that simultaneously satisfy transparency in governance and continuity in management. Listed pharmaceutical companies find themselves in a situation where they must find a 'sustainable governance' middle ground between companies seeking to continue family management and succession, and shareholders demanding accountability and transparency. It doesn't imply that owner-management or professional management is better, or that the Danish model is superior. Korean companies cannot simply replicate the Danish model. Denmark has a highly sophisticated legal framework for foundation-owned companies, whereas South Korea lacks clear public interest foundation laws or a tax incentive structure. In Korea's case, a strong perception exists that public interest foundations are often a means for illegal succession, due to past instances of irregular successions by some companies. However, the Danish model can serve as a meaningful reference point for the Korean pharmaceutical industry when redesigning its governance structure. The key is to reinterpret the Danish model and integrate it into a feasible structure that aligns with Korean culture, institutions, and management realities. In the pharmaceutical industry, where a long-term vision is essential, the sustainability of the entire industry could be jeopardized without careful consideration of governance. New ideas and discussions about new structures are urgently needed for the development of "K-made Wegovy."
- Policy
- Daewoong, Kolon enter Ofev generic market at the same price
- by Lee, Tak-Sun Jul 25, 2025 06:09am
- Daewoong Pharmaceutical and Kolon Pharma will additionally enter the generic market for “Ofev Soft Cap (Nintedanib Esylate),” a treatment for chronic fibrotic interstitial lung disease. Competition is expected to intensify in the market with two more generic versions entering the market following Yungjin and Ildong Pharmaceutical’s entry with their respective generic versions in July. Except for the Ildong Pharmaceutical product, the prices of the generic drugs were all set the same. According to industry sources on the 24th, Daewoong Pharmaceutical's Ofild Tab 100 mg and 150 mg and Kolon Pharma’s Effidanib Tab 100 mg and 150 mg will be reimbursed from August in Korea. These generic versions contain the same active ingredient as Ofev Soft Cap (nintedanib esilate), but differ in formulation — the original is a soft capsule, while the generics are in tablet form. Ofev was listed for reimbursement in May as a treatment for chronic fibrotic interstitial lung disease. It took nine years for the company to obtain reimbursement after receiving marketing authorization from the MFDS. There are currently no alternative therapeutic options recognized for chronic fibrosing interstitial lung diseases in Korea. However, the reimbursement came too late, as it came even after the drug’s substance patent expiry on January 25, 2025. Two months after Ofev was listed for reimbursement, its generic versions started to appear on the market. Youngjin Pharmaceutical's Nintebro Tab 100 mg and 150 mg, and Ildong Pharmaceutical's Cuninta Tab 150 mg were the first generics to be listed for reimbursement. A month later, Daewoong Pharmaceutical and Kolon Pharma also entered the generic market. Although all generic drugs are designated as orphan drugs and could have been priced the same as the original Ofev, all the companies decided to lower their prices. Coincidentally, except for Ildong Pharmaceutical, all other pharmaceutical companies set the same prices for their respective products. The companies’ 100mg dose version is priced at KRW 9,000, and the 150mg at KRW 15,000. Ildong Pharmaceutical's Cuninta Tab 150 mg is the cheapest at KRW 13,500. The original Ofev soft Cap cost KRW 29,600 for the 100 mg dose and KRW 26,220 for the 150 mg dose, which is about twice the price of the generic drugs. The generic drugmakers sought to quickly enter the market with low prices. In particular, with only a 2-3 month difference in release dates compared to the original, industry observers believe that the generic companies stand a chance of gaining an equal market share. The estimated annual national health insurance financial expenditure for listing Ofev was KRW 6.3 billion. This calculation is based on the assumption that approximately 329 patients will be prescribed 2 capsules per day. Although the claim amount is not large, at less than KRW 10 billion, pharmaceutical companies have entered competition because the market is essentially untapped. Latecomers are particularly expecting synergistic effects with pirfenidone, which is already used for idiopathic pulmonary fibrosis. This is because nintedanib is already being used without reimbursement for idiopathic pulmonary fibrosis, and the hospitals treating these patients tend to be the same institutions that prescribe pirfenidone. In a market where the original and generic drugs are launched almost simultaneously, all eyes are on who will emerge as the ultimate winner.
- Policy
- Reimb criteria established for Roche's DLBCL drug 'Polivy'
- by Lee, Tak-Sun Jul 25, 2025 06:08am
- The reimbursement criteria for Roche Korea's Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), have been successfully established by the Health Insurance Review & Assessment Service's (HIRA) Cancer Disease Review Committee (CDRC). This drug, which is garnering attention as the first DLBCL first-line treatment in 20 years, passed the CDRC on its third attempt. HIRA announced that reimbursement criteria were established for drugs, including Polivy, at the 6th CDRC meeting held on July 23, 2025. For Polivy, the reimbursement criteria were set for "combination therapy with rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone (R-CHP) in adult patients with previously untreated diffuse large B-Cell lymphoma (DLBCL)." Meanwhile, the reimbursement criteria have not been established for Polivy in combination with bendamustine and rituximab in adult patients with relapsed or refractory DLBCL who are not eligible for hematopoietic stem cell transplantation and have failed one or more prior therapies. Along with Polivy, reimbursement criteria were established for the new drug Darzalex SC (daratumumab) for "combination therapy with bortezomib, cyclophosphamide, and dexamethasone in newly diagnosed light chain (AL) amyloidosis patients." Reimbursement criteria have been established for Polivy (polatuzumab vedotin) and Darzalex SC (daratumumab). Expanded reimbursement criteria were approved for Neulasta Prefilled Syringe, Tecentriq, and Blincyto. Drugs that failed to receive the reimbursement criteria include Verzenio (abemaciclib). Expanded reimbursement criteria were approved for Neulasta Prefilled Syringe, Tecentriq, and Blincyto. For Neulasta, the reimbursement criteria were set for "reduction in the incidence of febrile neutropenia and the duration of neutropenia in patients receiving cytotoxic chemotherapy for malignant neoplasms." For Tecentriq, reimbursement criteria were established for "post-operative adjuvant therapy after resection and platinum-based chemotherapy in patients with Stage II-IIIA non-small cell lung cancer (NSCLC) where PD-L1 is expressed in ≥ 50% of tumor cells (TC)." For Blincyto, reimbursement criteria were set for "consolidation therapy for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL) in adults and children." The anticancer drugs for which reimbursement criteria have now been established will undergo final review for reimbursement coverage through negotiation with HIRA's Drug Reimbursement Evaluation Committee (DREC) and the National Health Insurance Service.
- Policy
- Eun-Kyung Jeong appointed as new MOHW Minister
- by Lee, Jeong-Hwan Jul 24, 2025 11:38pm
- With the appointment of Eun-kyung Jeong (60, Seoul National University College of Medicine) as Minister of Health and Welfare, efforts to institutionalize and legislate telemedicine, as well as to establish a prescription drug delivery system, are expected to gain momentum. The government will begin establishing specific measures to stabilize the supply of pharmaceuticals, including promoting generic prescriptions and limited introduction of International Nonproprietary Name (INN) prescriptions. In light of the government’s push to strengthen health insurance coverage, the possibility of reforming the pricing system for generic drugs is also increasing. For this, the new minister will be tasked with addressing demands from the pharmaceutical industry. On the 22nd, Minister Jung highlighted the key healthcare and pharmaceutical policies she expects to pursue during her inaugural speech. Rapid rollout of telemedicine and prescription drug delivery policies Minister Jung plans to establish a legal framework for telemedicine as a supplementary tool to in-person care, aiming to enhance the stability of the system. She plans to actively participate in the enactment of three bills on revising the Medical Service Act currently pending in the National Assembly that focus on institutionalizing telemedicine. In the process, a public electronic prescription system for telemedicine and a prescription drug delivery system will likely be established. Minister Jung has repeatedly emphasized her commitment to legislating telemedicine in a way that prevents intermediary platforms from dominating medical institutions and pharmacies, thereby avoiding disruption to the healthcare delivery system and the pharmacy ecosystem. Accordingly, detailed provisions for the regulation and oversight of telemedicine intermediary platforms are expected to be carefully incorporated during the legislative process. “In light of the need to ensure medical safety and convenience for the public, as well as to improve healthcare accessibility for vulnerable populations, it is essential to establish a legal framework for telemedicine and intermediary platform businesses to enable stable operation. We will gather opinions from various stakeholders, including the medical and pharmaceutical community, patient groups, private companies, and experts, to systematically establish a plan from the outset for the construction and operation of a public electronic prescription transmission system.” She added, “Telemedicine should be institutionalized in a way that ensures the safety of medical treatment and improves the quality of primary care, rather than expanding the profits of platforms. I hope that appropriate regulatory measures will be discussed in the National Assembly to address concerns that platforms may effectively demonize medical institutions and pharmacies or promote profit maximization.” Regarding the institutionalization of a drug delivery system to improve the effectiveness of telemedicine, Jung said, “We agree on the need to establish a drug delivery system,” but added, “However, we must also consider measures to address concerns about the pharmacy dependence within telemedicine platforms, market concentration of large pharmacies, and the collapse of the local pharmacy system.” Regarding the major point of contention, the scope of initial and follow-up telemedicine consultations, Minister Jung responded, “We will discuss the matter after evaluating the pilot program and comprehensively considering the opinions of experts, the medical community, and patients, but we will follow medical judgments and standards rather than administrative criteria.” Generic drug price cut is likely With Minister Jung’s appointment, there is a greater possibility that drug price reevaluation, which will reduce the prices of generic drugs that account for a large proportion of domestic pharmaceutical companies, will be activated. Although it is challenging to compare drug prices in real terms due to differences in economic scales, drug pricing systems, and health insurance systems across countries, Minister Jung’s view is that the price of generic drugs in Korea is higher compared to other major countries (A8). To provide optimal drug reimbursement within the limited health insurance budget, Minister Jung had previously stressed the need to manage drug prices at an appropriate level. Minister Jung’s solution involves reforming the drug pricing reimbursement system to ensure that profits from generic drug sales can be reinvested into new drug development, while also preventing excessive competition from a flood of generics with identical ingredients and manufacturing processes produced through contract manufacturing. In particular, regarding the post-market management of drug prices, such as regular re-evaluation of reimbursement prices and benefit criteria, Minister Jung reaffirmed plans to revise the pricing policy for generics, stating “I believe there is room for stronger oversight in the pricing system, particularly concerning generic drugs.” Improvement of measures for drug with unstable supply and review of INN prescriptions In order to resolve the issue of unstable drug supply, there is a possibility that a new supply response system with the nature of an intergovernmental consultative body will be established, or that relevant legislation such as the revision of the Pharmaceutical Affairs Act will be enacted. This is because Minister Jeong agreed on the need to break away from the current limitations of seeking solutions to the unstable drug supply situation only around essential medicines. During the hearing, Minister Jung stated, “Supply instability issues occur regardless of whether they are classified as essential medications, so the current support system that focuses on essential medications under the Pharmaceutical Affairs Act has limitations in addressing such issues. Therefore, it is necessary to revise the support system under the Pharmaceutical Affairs Act to enable policy intervention across all aspects of medicines with unstable supply, including the establishment of new support grounds and governance reforms.” In particular, unlike national essential medicines, there are no legal grounds for defining medicines with unstable supply, so the Minister agreed on the need to establish a separate definition. In addition, Minister Jung is likely to take proactive measures beyond diagnosing causes and providing customized support through public-private consultations on medicines with unstable supply, such as promoting substitute prescriptions and limited introduction of International Nonproprietary Name (INN) prescriptions. Minister Jung explained, “To enable flexible responses to drug supply instability situations, we have revised the Enforcement Decree of the Pharmaceutical Affairs Act to simplify the post-notification procedure for substitute prescriptions. We are currently constructing a support information system for post-notification of substitute prescriptions in line with the implementation date of the revised Enforcement Decree.” She further elaborated, “Additionally, to fulfill the new government's pledge to ensure the stable supply of essential medicines, we are considering the introduction of INN prescriptions for essential medicines with unstable supply.”
- Policy
- Jeong Eun-kyung views "orphan disease fund establishment"
- by Lee, Jeong-Hwan Jul 24, 2025 11:38pm
- Jung Eun-kyung, the candidate for Minister of Health and Welfare (MOHW), has expressed skepticism regarding the establishment of a separate fund to improve the National Health Insurance reimbursement rate for treatments for expensive, rare (orphan), and severe diseases. The rationale is that if the required financial scale for reimbursing high-cost drugs exceeds the fund's size, flexible fund operation becomes difficult. Jung stated her view that continuously expanding the scope of reimbursement should take precedence over establishing a separate fund. On July 17, Jung provided this response to a written inquiry from Democratic Party of Korea Representative Jeon Jin-suk during the parliamentary confirmation hearing. Representative Jeon had asked for Jung's stance on strengthening coverage for orphan and severe disease treatments by creating a separate dedicated fund to improve the National Health Insurance reimbursement listing system. Jung acknowledged that establishing and operating a separate fund for patients with orphan and severe diseases would have the advantage of allowing independent financial management. However, she did not prioritize improving the reimbursement rate. Jung stated, "If the required financial resources for high-cost treatments exceed the fund's scale, there is a concern that flexible operation would become difficult." She emphasized, "Therefore, continuously expanding the scope of reimbursement is primarily needed rather than establishing a separate fund." Jung added, "Currently, various support measures are in operation, including 'special calculation and improvement of standards' to alleviate out-of-pocket burdens and catastrophic medical expense support," and added, "We will strive to strengthen coverage for rare and severe disease patients." Regarding the introduction of an indication-specific drug pricing system for recently developed immunotherapies for cancer that have single components but multiple indications, Jung provided a principled answer that she would review it. Jung said, "It is necessary to review various systems to strengthen patient access to recently developed new drugs." However, she added, "We will review it comprehensively, considering its suitability for operation within the National Health Insurance system in Korea, the benefits of introducing the system, and its financial and social impact."
- Company
- Expanded reimbursement criteria for 'Enspryng'
- by Eo, Yun-Ho Jul 24, 2025 06:07am
- Product photo of Enspryng As the insurance reimbursement criteria for 'Enspryng' have been eased, the drug is expected to be more utilized. The Ministry of Health and Welfare (MOHW) recently announced an administrative announcement regarding the partial revision to the "Detailed Standards and Methods of Application for Health Insurance Benefits (Pharmaceuticals)," which includes expanding the reimbursement criteria for Roche Korea's Neuromyelitis Optica Spectrum Disorder (NMOSD) treatment, Enspryng (satralizumab). Accordingly, starting in August, the eligibility for Enspryng will be broadened from patients with two or more relapses within two years to those with one or more relapses within one year. Yet, unmet needs still exist. The reimbursement criteria for Enspryng are primarily for '4th-line treatment or later.' Currently, for NMOSD, azathioprine, an immunosuppressant, is used as first-line maintenance treatment. Following azathioprine treatment failure, mycophenolate or rituximab are reimbursed as second-line treatments, but these are off-label drugs without an NMOSD indication. In other words, Enspryng can only be used by patients who have failed rituximab treatment as a 3rd-line treatment. Therefore, future developments, including whether Enspryng will pursue further reimbursement expansion, remain to be seen. Enspryng is an officially approved treatment for adult aquaporin-4 antibody-positive NMOSD. It is a drug that selectively targets the Interleukin-6 (IL-6) receptor, a key pathogenic factor of the disease, to inhibit IL-6 signaling. A novel recycling antibody technology was used, enabling the drug to recirculate in the bloodstream, thereby extending the duration of its IL-6 inhibitory effect. Moreover, as the only subcutaneous injection formulation, it can be self-administered once every four weeks during maintenance therapy, enhancing patient convenience. Meanwhile, the efficacy of Enspryng was demonstrated through the SAkuraStar and SAkuraSky clinical trials conducted in adult aquaporin-4 (AQP4) antibody-positive NMOSD patients. In the AQP4 antibody-positive group of the SAkuraStar monotherapy trial, 76.5% of Enspryng-treated patients prevented relapse for 96 weeks, compared to a relapse prevention rate of 41.1% for the placebo group. Additionally, in the SAkuraSky trial, which evaluated the concomitant use of Enspryng with standard immunosuppressant therapy, the relapse prevention rate was 91.1% at 96 weeks, compared to 56.8% for the placebo.
- Policy
- Release of Boryung’s generic version of Stivarga imminent
- by Lee, Tak-Sun Jul 24, 2025 06:07am
- The price of the liver cancer drug Stivarga Tab 40mg (regorafenib, Bayer) will be adjusted following the termination of the risk-sharing agreement due to the anticipated listing of its generic versions. Among the many companies, Boryung is expected to be the first company to launch a generic version of Stivarga in Korea. According to industry sources on the 23rd, the maximum price of Stivarga Tab 40mg will be adjusted from KRW 28,110 to KRW 22,450 from August. This is a measure following the termination of the risk-sharing agreement. Stivarga entered into a refund-type risk-sharing agreement when it was listed for reimbursement in June 2016 as a treatment for gastrointestinal stromal tumor (GIST). In addition, from May 2018, a refund-type RSA has been additionally applied to Stivarga as a second-line treatment for hepatocellular carcinoma. Last year, the company also signed a third RSA renewal contract with the Health Insurance Review and Assessment Service. The current insurance price cap is set at KRW 28,110, different from the actual price. However, the insurance price cap of KRW 22,450, to which the price will be adjusted after the termination of the RSA deal, is the actual price. The RSA has been in effect for 9 years, but a variable–entry of generic versions has emerged. In November last year, Boryung Pharmacuetical received approval from the MFDS for Regoranib Tab 40 mg, a generic version with the same active ingredient as Stivarga. Regoranib demonstrated bioequivalence to Stivarga through a bioequivalence test. This drug is expected to be released on the market after August 29, when Stivarga's patent expires. The industry expects it to be distributed on the market from September. The termination of the RSA for Stivarga was decided at the Drug Reimbursement Evaluation Committee (DREC) meeting held in April. The committee concluded that, considering Stivarga 40mg is expected to remain reimbursable even after the marketing of an equivalent generic formulation, the product qualifies for early termination of the RSA and that termination negotiations are required. Since then, the company completed negotiations to terminate the risk-sharing agreement with NHIS, and the insurance price ceiling amount was adjusted. Last year, Stivarga’s outpatient prescription sales amounted to KRW 7.7 billion, a decrease of 16.8% compared to the previous year. Since February, Chong Kun Dang has been exclusively distributing the drug in Korea under a contract with Bayer.
